FDA Issues Final Guidance on Intent to Exempt Certain Medical Devices from Premarket Notification Requirements

Posted on: July 21, 2015 By:

On July 1, 2015 the FDA issued its final guidance regarding the intent to exempt certain unclassified medical devices, certain Class II medical devices, and certain Class I medical devices that are subject to the reserved criteria of section 510(l) … Continue reading →

Posted in FDA, guidance, medical devices

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FDA Issues New Draft Guidance on Medical Device Data Systems

Posted on: June 25, 2014 By:

On June 20, 2014, the Food and Drug Administration (FDA) issued draft guidance advising that the agency does not intend to enforce compliance with the regulatory controls that apply to medical device data systems, medical image storage devices and medical … Continue reading →

Posted in FDA, guidance, medical

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Summary of FDA’s Final Guidance on Dear Health Care Provider Letters

Posted on: April 23, 2014 By:

At the beginning of this year, the Food and Drug Administration (FDA) issued its final guidance on the content and format of Dear Health Care Provider (DHCP) letters. DHCP letters are correspondence, often in the form of a mass mailing … Continue reading →

Posted in consumer products, FDA, guidance, medical, pharmaceutical, Uncategorized

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Summary of FDA Guidance on Mobile Medical Apps

Posted on: November 4, 2013 By:

Overview On September 25, 2013, the FDA issued its final guidance explaining how it plans to regulate mobile medical applications, or “apps,” under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The guidance clarifies which mobile apps will be … Continue reading →

Posted in FDA, guidance, medical, medical devices, mobile

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